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201–232/232
guide criteria
201 Prevajalska redakcija
izobraževanje
States, directly or through competent international organisations, shall promote the establishment of generally accepted guidelines, criteria and standards for the transfer of marine technology on a bilateral basis or within the framework of international organisations and other forums, taking into account, in particular, the interests and needs of developing States.
Države podpirajo neposredno ali prek pristojnih mednarodnih organizacij uvajanje splošno sprejetih smernic, kriterijev in standardov za prenos pomorske tehnologije na dvostranskih temeljih ali znotraj mednarodnih organizacij in drugih forumov, pri čemer upoštevajo zlasti interese in potrebe držav v razvoju.
202 Prevajalska redakcija
izobraževanje
CELEX: 31991L0689
With regard to attribution of the properties 'carcinogenic`, 'teratogenic` and 'mutagenic`, and reflecting the most recent findings, additional criteria are contained in the Guide to the classification and labelling of dangerous substances and preparations of Annex VI (part II D) to Directive 67/548/EEC in the version as amended by Commission Directive 83/467/EEC (1).
Glede na pripis lastnosti "rakotvorno", "teratogeno" in "mutageno" ter zaradi nedavnih ugotovitev, dodatna merila vsebuje Vodič za razvrščanje in označevanje nevarnih snovi in pripravkov Priloge VI (del IID) k Direktivi 67/548/EGS v različici, kakor je bila spremenjena z Direktivo Komisije 83/467/EGS [15].
203 Prevajalska redakcija
izobraževanje
CELEX: 32000L0055
Without prejudice to Articles 5 and 6, the procedures for conformity assessment of ballasts as single components or incorporated in luminaires and the rules for the affixing and use of the CE conformity marking shall be in accordance with Module A of Council Decision 93/465/EEC and with the criteria set out in that Decision and in the general guidelines in the Annex thereto.
Brez poseganja v člena 5 in 6 so postopki za ugotavljanje skladnosti predstikalnih naprav, bodisi kot posameznih komponent bodisi vgrajenih v svetilke, ter pravila za pritrjevanje in uporabo oznake "CE" v skladu z Modulom A Sklepa Sveta 93/465/EGS in z merili, določenimi v navedenem sklepu ter v splošnih smernicah v Prilogi Sklepa.
204 Prevajalska redakcija
izobraževanje
CELEX: 32001L0036
A summary of all data and information provided under points 5.1 through 5.5, must be submitted, and include a detailed and critical assessment of those data in the context of relevant evaluative and decision making criteria and guidelines, with particular reference to the risks for man and animals that may or do arise, and the extent, quality and reliability of the data base.
Predložiti je treba povzetek vseh podatkov in informacij iz točk 5.1 do 5.5, vključno s podrobno in kritično oceno teh podatkov, skladno z ustreznimi merili in smernicami za vrednotenje in odločanje, s posebnim poudarkom na možnem ali dejanskem tveganju za ljudi in živali ter obsegu, kakovosti in zanesljivosti baze podatkov.
205 Prevajalska redakcija
izobraževanje
Such authorisation or regulation shall be in accordance with the relevant applicable criteria, guidelines and procedures adopted by the Commission in accordance with subparagraph (d) of Article 10 of this Annex. This provision shall not be taken to permit the dumping of disused offshore installations or disused offshore pipelines in contravention of the provisions of this Annex.
Tako dovoljenje ali uredba je v skladu z ustreznimi veljavnimi merili, smernicami in postopki, ki jih je Komisija sprejela po pododstavku (d) člena 10 te Priloge. Ta določba ne pomeni, da se dovoljuje odmetavanje izrabljenih morskih objektov in naprav ali cevovodov, ki je drugače po tej Prilogi prepovedano;
206 Prevajalska redakcija
izobraževanje
CELEX: 32001L0036
A summary of all data and information provided under paragraphs 7.1 through 7.5, must be submitted, and include a detailed and critical assessment of those data in the context of relevant evaluative and decision-making criteria and guidelines, with particular reference to the risks for man and animals that may or do arise, and the extent, quality and reliability of the database.
Predložiti je potrebno povzetek vseh podatkov in informacij iz odstavkov 7.1 do 7.5, vključno z izčrpno in kritično oceno teh podatkov, skladno z ustreznimi merili in smernicami za vrednotenje in odločanje, s posebnim poudarkom na možnem ali dejanskem tveganju za ljudi in živali ter obsegu, kakovosti in zanesljivosti baze podatkov.
207 Prevajalska redakcija
izobraževanje
Following the adoption of a regulation declaring the Block Exemption inapplicable in respect of certain vertical restraints on a particular market, the criteria developed by the relevant case-law of the Court of Justice and the Court of First Instance and by notices and previous decisions adopted by the Commission will guide the application of Article 81 to individual agreements.
Po sprejetju uredbe, s katero se razveljavi uporaba uredbe o skupinskih izjemah v zvezi z nekaterimi vertikalnimi omejitvami na določenem trgu, se člen 81 pri posameznih sporazumih uporablja v skladu z merili, ki izhajajo iz zadevne sodne prakse Sodišča Evropskih skupnosti in Sodišča prve stopnje ter iz obvestil in sklepov, ki jih je do takrat sprejela Komisija.
208 Prevajalska redakcija
izobraževanje
CELEX: 31994L0079
A summary of all data and information provided under paragraphs 5.1 through 5.10, must be submitted, and include a detailed and critical assessment of those data in the context of relevant evaluative and decision making criteria and guidelines, with particular reference to the risks for man and animals that may or do arise, and the extent, quality and reliability of the data base.
Predložiti je treba povzetek vseh podatkov in informacij, iz odstavkov od 5.1 do 5.10, ter podrobno in kritično oceno teh podatkov, ki se oblikuje skladno z ustreznimi merili in napotki za vrednotenje in odločanje, s posebnim poudarkom na možnem ali dejanskem tveganju za človeka in živali ter obsegu, kakovosti in zanesljivosti baze podatkov.
209 Prevajalska redakcija
izobraževanje
CELEX: 32004L0009
publish documents providing details of the (national) GLP compliance programme, including information on the legal or administrative framework within which the programme operates and references to published acts, normative documents (e.g., regulations, codes of practice), inspection manuals, guidance notes, periodicity of inspections and/or criteria for inspection schedules, etc.,
objaviti dokumente s podrobnostmi o (nacionalnih) programih skladnosti z DLP, vključno z informacijami o pravnih ali upravnih okvirih, znotraj katerih deluje program, in sklicevanja na objavljene predpise, normativne dokumente (na primer uredbe, pravila o ravnanju), priročnike za preglede, pisne napotke, periodičnost inšpekcijskih pregledov in/ali merila za program pregledov itd.,
210 Prevajalska redakcija
izobraževanje
CELEX: 31982L0471
Whereas an appropriate Community procedure is essential to adapt the provisions of the Annex and the guidelines laid down for the submission of dossiers relating to certain products and, where necessary, to fix criteria of composition and purity as well as the physico-chemical and biological properties of these products in the light of the development of scientific and technical knowledge;
ker je ustrezen postopek Skupnosti bistvenega pomena za prilagajanje določb Priloge in smernic, določenih za predložitev dokumentacije v zvezi z nekaterimi proizvodi in, če je primerno, za določitev meril glede sestave in čistote, pa tudi glede fizikalno-kemijskih in bioloških lastnosti teh proizvodov z vidika razvoja znanstvenega in tehnološkega znanja;
211 Prevajalska redakcija
izobraževanje
CELEX: 32000D0368
The guidance criteria set out in this Annex are directly applicable when the data in question have been obtained from test methods comparable with those described in Annex V. In other cases, the available data must be evaluated by comparing the test methods employed with those indicated in Annex V and the rules specified in this Annex for determining the appropriate classification and labelling.
Smernice, določene v tej prilogi, se neposredno uporabljajo, kadar so bili zadevni podatki pridobljeni iz preskusnih metod, primerljivih s tistimi, opisanimi v Prilogi V. V drugih primerih je treba razpoložljive podatke ovrednotiti s primerjavo uporabljenih preskusnih metod s tistimi, navedenimi v Prilogi V, in pravil za določitev ustrezne razvrstitve in označitve, določenih s to Prilogo.
212 Prevajalska redakcija
izobraževanje
CELEX: 31999D0337
Representatives from intergovernmental organisations and representatives from non-governmental organisations concerned with matters relevant to the implementation of this Agreement shall be afforded the opportunity to take part in meetings of the parties convened pursuant to Article VIII as observers or otherwise, as appropriate, in accordance with the guidelines and criteria set forth in Annex X.
Predstavnikom medvladnih organizacij in predstavnikom nevladnih organizacij, ki jih zadevajo vprašanja, pomembna za izvajanje tega sporazuma, se omogoči, da sodelujejo na zasedanjih pogodbenic, sklicanih na podlagi člena VIII, kot opazovalci ali kako drugače, kot je ustrezno, v skladu s smernicami in merili iz Priloge X.
213 Prevajalska redakcija
izobraževanje
CELEX: 32002L0059
Member States shall monitor and take all necessary and appropriate measures to ensure that all ships entering the area of a mandatory ships' routing system adopted by the IMO according to Regulation 10 Chapter V of the SOLAS Convention and operated by one or more States, of which at least one is a Member State, use the system in accordance with the relevant guidelines and criteria developed by the IMO.
Države članice spremljajo in sprejmejo vse potrebne in ustrezne ukrepe, s katerimi zagotovijo, da vse ladje, ki vplujejo v območje sistema obvezne organizacije ladijskega prometa, ki ga je sprejela IMO v skladu s pravilom 10 poglavja V Konvencije SOLAS in ga uporablja ena država ali več, od katerih je vsaj ena država članica, uporabljajo sistem v skladu z ustreznimi smernicami in merili, ki jih je izdelala IMO.
214 Prevajalska redakcija
izobraževanje
CELEX: 32004R0641
In addition, Regulation (EC) No 1829/2003 provides that the European Food Safety Authority (the Authority) is to publish detailed guidance to assist the applicant in the preparation and the presentation of the application, concerning notably the information and data to be provided in order to demonstrate that the product complies with the criteria referred to in Articles 4(1) and 16(1) of that Regulation.
Uredba (ES) 1829/2003 tudi določa, da mora Evropska agencija za varno hrano (Agencija) objaviti podrobna navodila za pomoč vlagateljem pri pripravi in predložitvi vloge, ki se nanašajo na informacije in podatke, ki jih je treba posredovati in ki dokazujejo, da proizvod izpolnjuje merila iz členov 4(1) in 16(1) navedene uredbe.
215 Prevajalska redakcija
izobraževanje
CELEX: 32001L0083
For all controls of biological medicinal products such as immunological medicinal products and medicinal products derived from human blood or plasma which are not specified in the European Pharmacopoeia or failing this, in the pharmacopoeia of a Member State, the procedures and the criteria of acceptability published as recommendations in the WHO (Requirements for Biological Substances) shall serve as guidelines.
Za vse kontrole bioloških zdravil, kot so imunološka zdravila in zdravila, pridobljena iz človeške krvi ali plazme, ki niso navedena v Evropski farmakopeji ali, če jih ta ne vsebuje, v farmakopeji države članice, se kot smernice uporabljajo postopki in merila sprejemljivosti, objavljeni kot priporočila WHO (Zahteve za biološke snovi).
216 Prevajalska redakcija
izobraževanje
The Commission Communication of 27 November 1996 on Assessment Criteria for National Schemes for the Costing and Financing of Universal Service and Guidelines for the Operation of such Schemes will be relevant for the determination of the extent to which the universal service obligation can be used to justify additional charges related to the sharing of the net cost in the provision of universal service (COM(96) 608).
Sporočilo Komisije z dne 27. novembra 1996 o merilih za ocenjevanje nacionalnih programov za izračunavanje stroškov in financiranje univerzalne storitve in smernice za delovanje takšnih programov bo pomembno za določanje obsega, do katerega se lahko uporabijo obveznosti univerzalne storitve za utemeljitev dodatnih stroškov, povezanih z delitvijo neto stroškov pri uporabi univerzalne storitve (COM(96) 608).
217 Prevajalska redakcija
izobraževanje
CELEX: 32004L0027
The marketing authorisation holder shall be required to record and report all other suspected serious adverse reactions which meet the notification criteria in accordance with the guidelines referred to in Article 106(1), of which he can reasonably be expected to have knowledge, promptly to the competent authority of the Member State in whose territory the incident occurred, and no later than 15 days following the receipt of the information.
Imetnik dovoljenja za promet z zdravilom vodi dokumentacijo in takoj poroča o vseh drugih domnevnih resnih neželenih učinkih, ki izpolnjujejo merila o poročanju v skladu s smernicami iz člena 106(1), za katere se utemeljeno pričakuje, da je o njih obveščen, pristojnemu organu države članice, na ozemlju katere so se pojavili, najpozneje v 15 dneh po prejetju informacije.
218 Prevajalska redakcija
izobraževanje
CELEX: 31997D0264
For the purposes of Article 12 of Regulation (EEC) No 1836/93, the Commission hereby recognizes that accreditation according to the criteria laid down in any one of the following approaches to the accreditation of certification bodies will ensure that appropriate certification procedures are employed by certification bodies, acting within the scope of their accreditation, who have been accredited according to these requirements and guidelines:
Za namene člena 12 Uredbe (EGS) št. 1836/93 Komisija s tem priznava, da bo akreditacija pridobljena v skladu z merili, predpisanimi v katerem koli od naslednjih postopkov za akreditacijo certifikacijskih organov, zagotovila uporabo ustreznih certifikacijskih postopkov teh organov, ki delujejo v obsegu svoje akreditacije in so bili akreditirani v skladu s temi zahtevami in navodili:
219 Prevajalska redakcija
izobraževanje
CELEX: 32001L0079
The environmental impact of feed additives is important since the additives are normally used over a long period, and the abovementioned guidelines should therefore be supplemented by the establishment of criteria for the assessment of the risk of the additive having an adverse effect on the environment, either directly and or as a result of the effect of products derived from it, whether directly or excreted by the animals into the environment.
Vpliv krmnih dodatkov na okolje je pomemben, saj se dodatki običajno uporabljajo daljše obdobje, zato je treba zgoraj navedene smernice dopolniti z uvedbo meril za oceno tveganja škodljivosti vpliva dodatka na okolje, ali neposredno ali kot rezultat učinka proizvodov, ki izhajajo iz njega, ali neposredno ali skozi izločke živali v okolje.
220 Prevajalska redakcija
izobraževanje
CELEX: 32001L0083
For biological medicinal products, such as immunological medicinal products and medicinal products derived from human blood or plasma, the procedures and the criteria of acceptability published as recommendations of the WHO (Requirements for Biological Substances) shall serve as guidelines for all controls of production stages which are not specified in the European Pharmacopoeia, or falling this, in the national pharmacopoeia of a Member State.
Pri bioloških zdravilih, kot so imunološka zdravila in zdravila, pridobljena iz človeške krvi ali plazme, se kot smernice za vse nadzore faz proizvodnje, ki niso navedene v Evropski farmakopeji ali farmakopeji države članice, upoštevajo postopki in merila sprejemljivosti, objavljeni kot priporočila WHO (Zahteve za biološke snovi).
221 Prevajalska redakcija
izobraževanje
CELEX: 32001L0083
For all controls of biological medicinal products, such as immunological medicinal products and medicinal products derived from human blood or plasma, which are not specified in the European Pharmacopoeia, or failing this, in the national pharmacopoeia of a Member State, the procedures and the criteria of acceptability published as recommendations in the World Health Organization (Requirements for Biological Substances) shall serve as guidelines.
Pri vseh kontrolah bioloških zdravil, kot so imunološka zdravila ter zdravila, pridobljena iz človeške krvi ali plazme, ki niso navedene v Evropski farmakopeji ali v nacionalni farmakopeji države članice, se kot smernice uporabljajo postopki in merila sprejemljivosti, objavljeni kot priporočila WHO (Zahteve za biološke snovi).
222 Prevajalska redakcija
izobraževanje
CELEX: 31997D0264
Whereas the Commission has been requested to recognize that accreditation according to the criteria laid down in any one of the following approaches to the accreditation of certification bodies in the field of environmental management systems will ensure that appropriate certification procedures are employed by certification bodies, acting within the scope of their accreditation, who have been accredited according to these requirements and guidelines:
ker je bila Komisija zaprošena za priznanje, da bo akreditacija, pridobljena v skladu z merili, določenimi v enem od naslednjih postopkov za akreditacijo certifikacijskih organov na področju sistemov okoljskega upravljanja, zagotovila uporabo ustreznih certifikacijskih postopkov teh organov, ki delujejo v okviru svoje akreditacije in so bili akreditirani v skladu s ustreznimi zahtevami in navodili:
223 Prevajalska redakcija
izobraževanje
CELEX: 32001L0083
The marketing authorization holder shall be required to record and report all other suspected serious adverse reactions which meet the reporting criteria in accordance with the guidance referred to in Article 106(1) of which he can reasonably be expected to have knowledge immediately to the competent authority of the Member State in whose territory the incident occurred, and in no case later than 15 calendar days following the receipt of the information.
Od imetnika dovoljenja za promet z zdravilom se zahteva, da vodi dokumentacijo in takoj poroča o vseh drugih domnevnih resnih neželenih učinkih, ki izpolnjujejo merila o poročanju v skladu z navodili, navedenimi v členu 106(1), za katere se od njega lahko smiselno pričakuje, da bo o njih obveščen, pristojnemu organu države članice, na katere ozemlju se pojavijo, najpozneje pa v 15 koledarskih dneh po prejetju informacije.
224 Prevajalska redakcija
izobraževanje
CELEX: 32003R1829
a copy of the studies including, where available, independent, peer-reviewed studies, which have been carried out and any other material which is available to demonstrate that the feed complies with the criteria referred to in Article 16(1), and, in particular for feed falling within the scope of Directive 82/471/EEC, the information required under Council Directive 83/228/EEC of 18 April 1983 on the fixing of guidelines for the assessment of certain products used in animal nutrition(28);
kopija študij, vključno - kadar so na voljo - z neodvisnimi, strokovno pregledanimi študijami, ki so bile izvedene, in kakršnim koli drugim razpoložljivim gradivom, s katerim se lahko dokaže, da krma izpolnjuje merila iz člena 16(1), ter, zlasti pri krmi s področja uporabe Direktive 82/471/EGS, informacije, zahtevane z Direktivo Sveta 83/228/ES z dne 18. aprila 1983 o določitvi smernic za ocenjevanje nekaterih proizvodov, ki se uporabljajo v prehrani živali [28];
225 Prevajalska redakcija
RS
EMEA
The treatment regimens that have been shown to satisfy the criteria required above were following: Standard dose proton pump inhibitor, twice daily, and: • metronidazole, 400 mg (tinidazole, 500 mg) twice daily, + clarithromycin, 250 mg twice daily; • amoxicillin, 1000 mg twice daily, + clarithomycin, 500 mg twice daily (advisable when metronidazole resistance is likely); • amoxicillin, 500 mg three times daily, + metronidazole, 400 mg three times daily (advisable when clarithomycin resistance is likely) Since then new data became available that necessitated an update of the original guidelines in order to provide practical management guidelines that would be acceptable across clinical practice, both in primary care and the specialist level.
Sheme zdravljenja, ki so ustrezale gornjim merilom, so bile naslednje: standardni odmerek zaviralca protonske črpalke, dvakrat dnevno, ter: • metronidazol, 400 mg (tinidazol, 500 mg) dvakrat dnevno, + klaritromicin, 250 mg dvakrat dnevno • amoksicilin, 1000 mg dvakrat dnevno, + klaritromicin, 500 mg dvakrat dnevno (priporočeno, kadar je možna odpornost na metronidazol); • amoksicilin, 500 mg trikrat dnevno, + metronidazol, 400 mg trikrat dnevno (priporočeno, kadar je verjetna odpornost na klaritromicin); Od takrat so bili na razpolago dani novi podatki zaradi katerih je bilo potrebno smernice posodobiti, da bi tako zagotovili praktična priporočila za obvladovanje, ki bi bila sprejemljiva po vsej klinični praksi, tako v osnovnem zdravstvu kot na specialistični ravni.
226 Prevajalska redakcija
izobraževanje
CELEX: 32004R0021
The Commission, in particular in the light of the proceedings conducted by its Joint Research Centre, should also provide detailed technical guidelines, definitions and procedures for the technical characteristics of identifiers and readers, test procedures, acceptance criteria and the certification model for approved test laboratories, the procurement of appropriate identifiers and readers, the application of identifiers, their reading and recovery, the codification of identifiers, a common glossary, a data dictionary and communication standards.
Komisija bi morala, zlasti v zvezi s postopki, ki jih vodi Skupno raziskovalno središče, pripraviti podrobne tehnične smernice, opredelitve in postopke za tehnične značilnosti identifikacijskih oznak in čitalcev, preskusne postopke, merila sprejemljivosti in vzorce certificiranja za pooblaščene testne laboratorije, za nabavo primernih identifikacijskih oznak in čitalcev, za nameščanje identifikacijskih oznak, njihovo odčitavanje in odvzem, kodifikacijo identifikacijskih oznak, enotno terminologijo, podatkovni slovar in komunikacijske standarde.
227 Prevajalska redakcija
izobraževanje
CELEX: 32002L0059
The Member State concerned shall monitor and take all necessary and appropriate measures to ensure that all ships entering the area of a mandatory ship reporting system, adopted by the IMO according to Regulation 11 Chapter V of the SOLAS Convention and operated by one or more States, of which at least one is a Member State, in accordance with the relevant guidelines and criteria developed by the IMO, comply with that system in reporting the information required without prejudice to additional information required by a Member State in accordance with IMO Resolution A.851(20).
Zadevne države članice spremljajo in sprejmejo vse potrebne in ustrezne ukrepe, s katerimi zagotovijo, da vse ladje, ki vplujejo v območje sistema obveznega poročanja z ladij, ki ga je sprejela IMO v skladu s pravilom 11 poglavja V Konvencije SOLAS in ga uporablja ena država ali več, od katerih je vsaj ena država članica, v skladu z ustreznimi smernicami in merili, ki jih je izdelala IMO, upoštevajo ta sistem pri sporočanju zahtevanih informacij brez poseganja v dodatne informacije, ki bi jih država članica zahtevala v skladu z Resolucijo A.851(20) IMO.
228 Prevod
promet
CELEX: 31999D0801
"Common guidelines, standards and criteria
" Splošne smernice, standardi in merila
229 Prevod
gospodarstvo
CELEX: 32002D0106
(a) provides guidelines and minimum requirements on diagnostic procedures, sampling methods and criteria for the evaluation of the results of clinical and post-mortem examinations and laboratory tests for a proper diagnosis of classical swine fever(1);
daje smernice in minimalne zahteve glede diagnostičnih postopkov, metod vzorčenja in meril za ocenjevanje rezultatov kliničnih, patoanatomskih preiskav in laboratorijskih preiskav za zanesljivo ugotavljanje klasične prašičje kuge [3];
230 Prevod
promet
The Conference of the Parties shall review the effectiveness of the mechanism established under this Article, including the criteria and guidelines referred to in paragraph 2, not less than two years after the entry into force of this Convention and thereafter on a regular basis.
Konferenca pogodbenic pregleda učinkovitost mehanizma, sprejetega na podlagi tega člena, vključno z merili in smernicami iz točke 2, najmanj dve leti po začetku veljavnosti te konvencije, nato pa redno.
231 Prevod
promet
To advise the executive board on guidelines and criteria for determining the relative priorities among measures within the scope of the second account, for appraisal procedures for making grants and loan assistance, and for co-financing with other international financial institutions and other entities;
svetovati izvršilnemu odboru o smernicah in merilih za določanje relativne prednosti med ukrepi v sklopu drugega računa, za oceno postopkov za dodeljevanje nepovratnih sredstev in posojil in za sofinanciranje z drugimi mednarodnimi finančnimi institucijami in drugimi subjekti;
232 Prevod
promet
Pursuant to the objectives of this Convention, the Conference of the Parties shall at its first meeting, determine the policy, strategy and programme priorities, as well as detailed criteria and guidelines for eligibility for access to and utilization of the financial resources including monitoring and evaluation on a regular basis of such utilization.
V skladu s cilji te konvencije konferenca pogodbenic na svojem prvem zasedanju določi politiko, strategijo in programske prednostne naloge kakor tudi podrobna merila in smernice za izpolnjevanje pogojev za dostop do finančnih virov in njihovo uporabo, vključno z rednim spremljanjem in ocenjevanjem te uporabe.
Prevodi: en > sl
201–232/232
guide criteria